The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
The Associate, Regulatory Affairs Submission Management, manages low to medium-impact submission projects involving multiple cross-functional regulatory submission teams. Job Title: Associate Regulatory Affairs Submission Management. With input from the submission teams, this individual establishes ...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strate...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (-day Notice, Real-Time Reviews, -Day Supplements, Annual Reports).Review/approval of engi...
Duration: 1 yearEmployment Type: W-2 Overview:The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains su...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timeli...
The Associate Director, Regulatory Strategic Planning is responsible for successfully delivering project management capabilities for highly complex, cross-functional teams within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business...
The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. ...
This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strate...
Associate Regulatory Operations Manager in Northbrook, IL to prepare, submit, distribute, and archive routine regulatory agency submissions. ...
The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medi...
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. May lead the Labeling Regulatory Strategy Team (LRST), and serv...
Senior Manager Medical Affairs Quality Assurance is responsible for providing independent quality oversight of GxP activities executed by AbbVies Medical Affairs enterprise, including but not limited to non-interventional studies, medical information and other regulatory commitments. Partner with Me...
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality...
You will work closely with HR solution technology and project teams, and employment compliance team, to identify, analyze, and mitigate compliance risks and issues. Manage responses to non-compliance events immediately upon discovery, ensuring HR's response is complete, stakeholders are appropriatel...
Work closely with cross-functional teams, including R&D, Software, Hardware, Quality Assurance, and Clinical Affairs to provide regulatory guidance and support regarding EU MDR compliance during development of products. You will work with cross-functional teams to provide technical regulatory leader...
The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medi...
Which includes: tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying awa...
Overview of the company in need of a Project Manager. Overview of the Project Manager opportunity:. Project Manager will assist with team recruitment for a cause. Project Manager will run reports and work with committee members. ...
As a Senior Analyst - Payroll Compliance you will be responsible for providing support to the payroll team by aiding in the development and maintenance of comprehensive procedural documentation. Generate reports from the payroll and timekeeping systems to assess audit and compliance risks while bein...
ARE YOU A COMMERCIAL OR INDUSTRIAL CONSTRUCTION ELECTRICAL PROJECT MANAGER?. Our Clients are Seeking Electrical Project Managers at all Levels!!. Gpac has been retained by several clients to search for qualified and interested Electrical Project Manager's. Total compensation for the Electrical Proje...
Manager, Regulatory Affairs - Labeling. Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improve...